Testing of samples for active ingredients by HPLC and GC, according to validated methods, or relevant pharmacopoeia. Organisation of lab activities on a day to day basis Physical/ Chemical Tests including: Identification, pH, TLC, Moisture, Mineral Analysis, Loss on Drying, ViscosityCalibration and Maintenance of lab equipment such as HPLC, GC, Balances, pH meters, Karl Fisher, UV Spec, FTIR, XRFValidation and implementation of new test methods Reviewing data for technical quality and compliance to protocols, methods and SOPs.

Raw Materials testing, according to current USP, Ph.Eur, and JP.

Preforming validation activities including: Equipment performance qualification; Cleaning validation; and product characterisation in line with PIC/S, Guide to Good Manufacturing Practice for Medicinal Products Part I and II and applicable Annexes.Assisting in development of Project Validation Plans and provide input to validation schedule. Creation of required validation protocols and reports, ensuring these meet CSL procedures and regulatory requirements.Assisting in review of validation related regulatory documentation.Providing technical specialist advice on validation issues to project and department team members, particularly with regards to Cleaning Validation.Preparation and implementation of departmental documentation for validation activities and regulatory submissions.

Working in a GMP environment, and following SOPs to perform various activities:Working in the lab as part of the QC Chemistry team performing routine testing procedures in support of testing targetsFinished Product testing including: A280 Concentration, pNP Activity testing, ID testing using immunochemical detection. Supporting Manufacturing department through QC Cleaning Verification using both qualitative (visual inspection) and quantitative (TOC, conductivity) methods.Involved in the installation and validation of lab equipment such as UV Spectrophotometers, Microscopes, and TOC analysers.EHS rep for lab, involved in risk assessing various lab activities, from a safety point of view. IOSH trained.Responsible for scheduling and facilitating the routine back-up of equipment based PCs within the QC Department Water tests: Heavy Metals, Nitrates, pH, Conductivity, and TOCCalibration and Maintenance of lab equipment such as UV Specs, UV Plate readers and TOC analysers. Sampling and Testing of Primary and Secondary packaging components for the Fill Finish operation Training other team members on equipment calibration and assays